MoS Health Bharati Pawar lists out measures taken to ensure quality of medicines

New Delhi [India], February 9 : The Union Minister of State for Health and Family Welfare, Bharati Pravin Pawar, listed out in the Lok Sabha on Friday the measures taken by the government to ensure the quality of medicines in the country.
In his written reply, the Minister said that the Drugs and Cosmetics (Amendment) Act 2008 provides stringent penalties for the manufacture of spurious and adulterated drugs.
Before the grant of a manufacturing license, manufacturing establishments are to be mandatorily inspected jointly by the drug inspectors of the Central Government and State Government.
"Applicants now mandatorily need to submit evidence of stability and safety of excipients to the State Licensing Authority before the Authority grants a manufacturing licence," the Minister said.
Manufacturing, sale and distribution of drugs in the country are regulated by the State Licensing Authorities appointed by the respective State Government under the Drugs and Cosmetics Act 1945 and Rules. State Licensing Authorities (SLAs) are empowered to take action in case of violation of any condition of licenses.
The Minister said that, along with the Central Drugs Standard Control Organization (CDSCO), it has taken several regulatory measures to ensure the quality of medicines in the country.
"The Drugs and Cosmetics Act, of 1940 was amended under the Drugs & Cosmetics (Amendment) Act of 2008 to provide stringent penalties for the manufacture of spurious and adulterated drugs. Certain offences have also been made cognizable and non-bailable," the Minister said.
States/UTs have set up special Courts for the trial of offences under the Drugs and Cosmetics Act for speedy disposal.
According to the written statement, the number of sanctioned posts in CDSCO has increased from 111 in 2008 to 931 till date.
The Drugs and Cosmetics Rules, 1945, have been amended, making it mandatory that before the grant of manufacturing licence, the manufacturing establishment be inspected jointly by the Drugs Inspectors of the Central Government and State Government.
To ensure the quality of drugs and to assess the regulatory compliance of drug manufacturing premises in the country, the CDSCO along with State Drugs Controllers (SDCs) have conducted risk-based inspections of 275 premises.
The firms have been identified based on risk criteria like a number of drugs declared as Not of Standard Quality, complaints, criticality of the products etc. Based on the findings of inspections, more than 250 actions, like issuance of show cause notices, stop production order, suspension, cancellation of licenses/product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945.
CDSCO, Ministry of Health and Family Welfare regulates the quality, safety and efficacy of Drugs, Medical Device and Cosmetics in the country under the provisions of the Drugs & Cosmetics Act, 1940 and its Rules, the written statement said.